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510(k) Data Aggregation
(90 days)
Led Mask Platinum Md
LED MASK PLATINUM MD is an over the counter device that is indicated for the treatment of full face wrinkles.
This product irradiates the skin with red light in the wavelength range of 630 to 690 nm and infrared light in the wavelength range of 820 to 880 nm. Treatment of wrinkles all over the face. This product is designed as a portable personal medical device with a built-in battery, not a wired power supply. It is a mask-type product that is worn on the face. The operating mode of the product can be easily changed by hand. After connecting the charging adapter to the cradle, attach the main unit to the cradle to wirelessly charge the main unit with only the cradle. In addition, eye shield (for eye protection, opening/closing covers, vacuum cleaner towels, power cables, etc. are provided for convenient service use.
This document is a 510(k) summary for the LED MASK PLATINUM MD, a device indicated for the treatment of full face wrinkles. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to predicate devices, particularly K180856, and by conforming to established safety standards for LED-based devices. The "reported device performance" section focuses on technical specifications and safety compliance rather than direct clinical efficacy metrics.
| Acceptance Criteria (Implied) | Reported Device Performance (LED MASK PLATINUM MD) |
|---|---|
| Intended Use: Treatment of full face wrinkles | Indicated for the treatment of full face wrinkles. |
| Type of Use: Over-the-Counter (OTC) | OTC |
| Device Configuration: Mask type | Mask type |
| Wavelengths: Within acceptable range for wrinkle treatment | 630-690 nm (red light), 820-880 nm (infrared light) |
| Power (Irradiance): Within safe and effective range. Specifically, within 1.32 mW/cm2 to 62 mW/cm2 based on cleared OTC devices. | 2 mW/cm2 |
| Treatment Time: Comparable to predicate devices. | 8 minutes |
| Energy Dose: Comparable to predicate devices. | 0.96 J/cm2 |
| Safety: Compliance with relevant electrical, radiation, and risk management standards. | ES 60601-1 (Basic safety & essential performance), IEC 60601-1-2 (EMC), IEC 62471 (Photobiological safety), IEC 60601-2-57 (Safety of laser product), ISO 14971 (Risk management), IEC 60601-1-6 (Usability), IEC 60601-1-11 (Home healthcare environment) |
| Effectiveness: Substantial equivalence to predicate device with similar intended use. | Claims substantial equivalence to predicate devices (e.g., K180856). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical study with a "test set" in the traditional sense of evaluating device efficacy on patients. The performance data presented relates to non-clinical tests (measurement of wavelength, output power, total irradiance, and safety compliance). Therefore, no sample size for a test set or data provenance from patient data is applicable or reported for this type of submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As no clinical "test set" data is presented for efficacy, there is no mention of experts establishing ground truth for such a set. The expertise involved would be in the engineering and safety testing domains, not clinical adjudication.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an LED mask for wrinkle treatment, not an AI-assisted diagnostic tool. An MRMC study is not relevant to this device's regulatory pathway.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device. The device's performance is standalone in the sense that it directly emits light for treatment, not that it's an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through physical measurements and compliance with recognized consensus standards.
- For technical specifications (wavelength, power, energy dose): The ground truth is the direct measurement of these physical properties using calibrated equipment.
- For safety: The ground truth is established by demonstrating compliance with the referenced IEC and ISO standards (e.g., IEC 60601-1 for basic safety, IEC 62471 for photobiological safety, ISO 14971 for risk management).
- For substantial equivalence: The ground truth is the regulatory determination that the device's technical characteristics, intended use, and performance are sufficiently similar to a legally marketed predicate device to be considered equally safe and effective.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" as it is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is described.
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